510(k) K915548
- Device
- Ionguard Titanium Modular Heads
- Applicant
- BIOMET, INC.
- 510(k) number
- K915548
- Product code
- LZY
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 1992-03-10
- Date received
- 1991-12-11
- Regulation
- 888.3360
- Classification name
- Prosthesis, Hip, Hemi-, Femoral, Metal Ball
- Medical specialty
- Orthopedic
- Review panel
- Orthopedic
- Device class
- 2
- Clearance type
- Traditional
- Statement or summary
- Statement
- Third party reviewed
- No
Applicant Contact#
- Contact
- PATRICIA S BERES
- Address
- P.O. Box 587 Airport Industrial Park Warsaw IN US 46581 46581
FDA Registration Numbers#
- 1219655
- 3036756245
- 3038503932
- 8044172
- 3015207155
- 9616671
- 8043792
- 3009973336
- 1818910
- 8010379
- 3004748528
- 1828464
- 2249615
- 3005061536
- 3009888740
- 9681465
- 1450662
- 3013302242
- 3021008900
- 1834331
- 3012725451
- 3005180920
- 3011295718
- 3008744062
- 3006085220
- 3006356043
- 1020279
- 9613369
- 3006017180
- 3008812251
- 1825034
- 3033509898
- 3008110533
- 3013176080
- 3015516266
- 3001278222
- 1643264
- 1833506
- 3002907620
- 3009973505
- 3035366890
- 1043653
- 3007366790
- 1221053
- 3016438694
- 3008868758
- 3014302784
- 3006395932
- 1526534
- 1529009
- 3025603301
Source Documents#
510(k) summary PDF not indicated by FDA
Other 510(k) Records For Product Code LZY#
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K231448 | TANDEM Hip System | Smith & Nephew, Inc. | 2023-07-19 |
| K111145 | ENDO HEAD | Medacta International | 2011-08-16 |
| K974442 | PRE-POWDERED NITRILE EXAMINATION GLOVES | P.T. Latexindo Tobaperkasa | 1998-01-05 |
| K915528 | BHR BIPOLAR FEMORAL HEAD COMPONENT | Implantology Corp. | 1993-06-29 |
| K903084 | MODULAR CATHCART FRACTURE SYSTEM | Depuy, Inc. | 1990-10-03 |
| K896580 | UNI-POLAR HEAD | Richards Medical Co., Inc. | 1990-02-15 |
| K892059 | FEMORAL HEADS/MODULAR & FIXED W/ TITAN NITRIDE SUR | Protek, Inc. | 1989-07-19 |